SARACA Medical Technologies on New European Medical Device Regulation: changes, challenges and implementation
The European Medical Device Regulation 2017/745 (MDR) passed the European Parliament on April 5, 2017 and will be operational starting in May 26, 2020. The regulation has significant economic impact on manufacturers,due to the cost of implementation of new regulations for new devices and ensuring that legacy products meet the new requirements. There will be no grandfathering of existing products from the current EU Medical Devices Directive (MDD). The MDR also strongly affects distributors and importers. The aim of these new regulations is to ensure that products are effective and safe as well as can be freely and fairly traded throughout the Europe.The existing rules that currently govern medical devices date back to the 1990s and have not kept pace with the significant innovations in technology and science.
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CLIENT TESTIMONIALS
We work continuously to receive customer feedback to provide them unmatched value. Here is what they say about us.
“Toby has had a smooth journey with Saraca Solutions. They have provided us with both a highly experienced Quality Manager and a very energetic Quality Engineer. Specifically, I would like to thank Saraca for closing our NCs in a timely manner while simultaneously performing a gap analysis on our entire QMS. Additionally, in preparation for an upcoming ISO audit, Saraca performed an internal audit on all of our major Quality subsystems. Lastly, Saraca Solutions faced our 2017 ISO audit, hand in hand with our staff, at Toby headquarters. I appreciate the end to end support provided by Saraca Solutions. This magnitude of interaction is unique among engineering services companies in the area of medical devices."
"Saraca was extremely helpful to our Product Team’s understanding of the requirements of ISO 13485 by presenting it to them in a simple and effective manner. They have also done a commendable job in helping us to align our deliverables in-line with the ISO 13485 requirements. With their help, our team was able to understand & implement the ISO 13485:2016 requirements effectively within a short duration. Their planning and execution methodology is superb. Overall, we are very happy with the outcome of our association with Saraca Solutions."
“Our team has partnered well with SARACA Solutions as we continue the development process for submitting one of ENT products for 510(k) review with US FDA. They constructed and maintain a Design History. They are also working on Risk Analysis as defined by our Quality Management System. The SARACA team has shown the depth of their experience working in the industry while seamlessly integrating well with us. In addition, their methods of collaboration ensure effectively developing the documentation and processes for our product management.”